System for tracking biological samples

ABSTRACT

Systems, methods, and apparatus are described for the handling of biological specimens for analysis. The systems, methods and apparatus are designed to reduce errors in misidentification, incorrect processing, and recordkeeping and reporting. The systems, methods, and apparatus can also provide real time tracking of samples at any stage, from collection to processing to analyzing to storage.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation application of and claims, under 35U.S.C. §120, the benefit of priority to U.S. patent application Ser. No.11/642,253, filed Dec. 19, 2006, which is a Divisional application ofand claims, under 35 U.S.C. §120, the benefit of priority to U.S. patentapplication Ser. No. 10/294,996, filed Nov. 13, 2002, which claims thebenefit of priority under 35 U.S.C. §119(e) to U.S. ProvisionalApplication No. 60/332,948, filed Nov. 13, 2001, the contents of each ofwhich applications are incorporated by reference in their respectiveentirety for all purposes.

TECHNICAL FIELD

This invention relates to the field of laboratory science and moreparticularly to the systems, methods and apparatus that can be used inthe laboratory.

BACKGROUND

Advances in science have made it possible to extract a wide variety ofinformation about an individual from a biological sample obtained fromthat individual. For example, it can assess the health, identifypossible future health issues, and provide the genetic makeup of theindividual. The results of any analysis, however, loose much of theirbeneficial qualities when the analysis is attributed to the wrongindividual or if the sample is processed incorrectly.

Much, if not all, of these analyses are processed in laboratories. Thelaboratory usually obtains its samples from institutions, such as thehospital, clinic, or police, and from individuals, such as samples sentto it from individuals using, for example, a Home HIV test kit. In theselaboratories, many samples are processed daily where they may passthrough many sets of hands and potentially be subjected to manydifferent tests. Each time a sample is handled, there is the potentialfor an error to occur. In many cases, a human operator is the source ofthe error. For example, in the collection of the sample, the sampleshould be clearly identified, e.g., from whom the sample was obtained.Samples, however, once removed from their natural environment, such asan individual's person, tend to look very similar to other samples oflike kind. Because of this, mix-ups have been known to happen when theinformation was incorrectly transcribed, labels were placed on the wrongsamples, or the identifying information was inadvertently omitted or wasincomplete. Moreover, errors can occur in the processing steps as well,such as the wrong reagents being used or the wrong tests beingperformed. It is, therefore, desirable that laboratories implementsystems, methods, and apparatus for maintaining the fidelity of theirwork, i.e., the proper analysis on the right sample and being able toreport the same to the person who ordered the test.

To prevent errors of this kind, elaborate and costly systems ofpaperwork are used. Current systems may also use barcodes to identifythe samples, such as patient information, as well as barcodes to carryother information, such as instructions about tests to be run. Often,this leads to a need to use multiple barcodes, each directing a specificfunction or holding information related to the sample. Because of thelimited space available for these barcodes on sample containers or ofthe risk of confusion, one barcode may need to be placed over another inorder to run the slide on more than one test. Alternatively, the oldbarcodes can be removed; however, it must be done without removing thebarcode holding needed information, such as the patient information.Moreover, since most barcodes look similar, the more widespread the useof barcodes for each specific task or bit of information, the greaterthe likelihood of placing the wrong barcode on a sample, possiblymisidentifying the sample and/or providing incorrect instructions forhandling the sample.

Once a sample is collected, it is labeled, or otherwise identified, andsent to a laboratory for further processing. For example, in a hospitalsetting, a health care provider will collect samples from a patient.These samples might be biopsies (pieces of tissue removed surgically) orother samples from a person including samples of blood, urine, stool,scrapings from the skin, or any other location, hair etc. Typically oneor more samples are bagged, labeled and sent to a laboratory with a workorder that specifies what diagnostic tests are to be performed on them.The laboratory may be in the same building as where the sample wascollected or it may be in another facility or even in another country.The laboratory may even forward the sample or a portion of the sample toyet another laboratory to do tests it cannot perform.

Once the sample arrives at the laboratory to be processed, the sample isprepared for analysis. For example, the sample can be taken to agrossing station. At the grossing station, the sample is removed fromits container and the desirable portions of the sample can be extractedand placed in the appropriate setting for further processing. Forexample, the portions can go into small baskets called cassettes, whichare used to carry the samples while they are fixed and embedded in wax.Once embedded, the samples can be sliced on a microtome and placed onslides. Since the slices are very thin (microns) many slides canpotentially be made from one cassette. While slides are described, otherreceptacles for holding the sample are used in the laboratory, and theyare contemplated for use herein, for example, tubes, cuvettes, biochips,and microplates, to name just a few. In each case, the source of theextracted portions of the sample must be correctly identified.

From here, the slides with the sample may go on to be specificallytreated for the test to be ran on it, such as staining with reagents.The types of reagents used will depend upon the test that is to beperformed. Slides can be stained with a variety of chemicals that willmake relevant cells, germs or other structures visible. Once the slidesare processed, they can be read by an automated microscope, such as anACIS (Automated Cell Image System) or by an individual through amicroscope. A pathologist can examine the slide or the image of theslide and issue a diagnostic report that can be sent back to theclinician. Throughout this process, the user should ensure that all theslides are identified properly and that the proper test is beingperformed.

A fluid sample can be processed in a similar manner except that, insteadof the grossing and microtome steps, the cells in the sample can be spundown with a centrifuge and transferred to a slide. Smears may be applieddirectly to a slide by hand. There are a number of other patented andnon-patented methods of getting cells onto a slide that could be used inconjunction with the system described herein.

SUMMARY

In one general aspect, the invention contemplates a laboratory or anetwork of laboratories equipped with readers (scanners) such as barcodereaders, magnetic strip readers, keyboards, or a similar device that can“input” data directly or indirectly into a computer or computer system,such as Optical Character Recognition (OCR) readers. It is envisionedthat these scanners can be located at desired area in the laboratory orthroughout the facility, e.g., at one or more of the following areas,including but not limited to, the grossing stations, microtome, reagentdispensing stations, automated cell image analysis stations, or storageareas.

In another general aspect, the samples are assigned a unique identifiercomposed of numbers, letters, and/or symbols. The identifier can be inhuman readable text and/or computer readable text. In one embodiment,the identifier is a universal unique identifier (UUID). Theseidentifiers are unique across both space and time. Use of UUIDs does notrequire a registration authority for each identifier; instead, it uses aunique value over space for each UUID generator. Methods and algorithmsfor generating unique identifiers are known in the art, for example,UUIDLib is a Macintosh shared library that generates UUID identifiers.Global unique identifiers (GUID) are used by Microsoft to identifyanything related to its system. One source of information about uniqueidentifiers is the world wide web. The unique identifier can be read bya human and/or by a computer (e.g., scanners). In other embodiments, theidentifiers are generated from one source that dispenses identifierssequentially. In still, other embodiments, algorithms used in computersgenerate a unique 128 bit number. Other methods of generating a uniqueidentifier are known to those skilled in the art.

Once assigned, the unique identifier remains associated with theparticular sample. Other samples derived from the original sample, suchas when the sample is being processed at the grossing station, areassigned their own unique identifier. In one embodiment, the uniqueidentifier is merely an identifier. In another embodiment, the uniqueidentifier can also provide information about the identifier, such asthe location of where and/or when the identifier was assigned, basedupon a characteristic of the identifier. For example, identifiers thatbegin with 01 can be designated to have originated from a particularfacility. In certain embodiments, the identifier does not hold anyinformation pertaining to the sample. In other words, the identifierdoes not hold any information about the source of the sample, the teststo be run on it, or what other samples may be related to it. The uniqueidentifier can be read by scanners or otherwise inputted into acomputer, such as by hand. Once in the computer, the information can betransmitted to a database.

In another general aspect, a central database can be utilized to houseall the information associated with the sample. The central database canstore any and all information about the sample, source information, thetests to be performed, the results obtained from the tests, and thelocation of the sample, to name just a few examples of the type ofinformation. The data in the central database can be updated each timenew information is received. In certain embodiments, the centraldatabase receives and stores information about the sample, such as thename of the patient (source) and other identifying information, type ofsample, when collected, and who collected it. The central database canalso receive and store information about what tests are to be performed.It can also receive and store information about when it was checked intothe lab. The central database can also receive and store informationabout how the sample was processed, what reagents were used and when itwas done, and whether there are other samples prepared from the originalsample and information relating to them, or otherwise linking the dataabout the original sample and the data from all samples derived from it.The central database can receive and store the results of the tests. Thecentral database can also receive and store information about additionaltests to be run or changes to existing orders. The central database canalso allow approved users to access this information. In certainembodiments, the data can be accessed from a terminal in close proximityto the laboratory or the database, or from a remote location, over theLAN, WAN, VPN or the world wide web.

In another general aspect, the central database may be in communicationwith the readers or scanners for inputting the unique identifies, suchas the barcode readers The central database may be in communication withthe equipment in the laboratory, such as the microtome, centrifuge,reagent dispensers, and automatic image analyzer, to name just a fewpieces of equipment found in laboratories. The readers or scanners mayalso be in communication with the equipment, so that all three,scanners, equipment, and the central database are in communication witheach other.

In another general aspect, the invention contemplates a computer systemincluding a database having records to the identity of a biologicalsample collected from a subject and the identity of a diagnosticanalysis to be performed on the biological sample and a remote userinterlace, such as readers, scanners, display screens, printers andcomputer terminals, capable of receiving and/or sending the records, foruse in matching the biological sample with the diagnostic analysis to beperformed on the biological sample.

In another general aspect, the invention contemplates acomputer-assisted method for processing a biological sample including:using a programmed computer including a processor, an input device, andan output device, including inputting into the programmed computer,through the input device (readers, scanners, mouse, keyboard), dataincluding the identity of a biological sample collected from a subjectand the identity of a diagnostic analysis to be performed on thebiological sample; determining, using the processor, the parameters ofthe diagnostic analysts; and outputting, to the output device, displayscreens or printers, the results of the diagnostic analysis.

In another general aspect, the invention includes methods for theautomated analysis of a biological sample, including the steps of:providing a user with a mechanism for electronically communicating theidentity of a biological sample collected from a subject and theidentity of a diagnostic analysis to be performed on the biologicalsample; providing the biological sample with a unique identifier;providing the diagnostic analysis with a unique identifier; optionallyproviding the user with an opportunity to communicate a desiredmodification to the diagnostic analysis; allowing the user to transmitany of the above identified information to a server; allowing a seconduser to obtain the information from the server; correlating theinformation with the biological sample; performing the diagnosticanalysis on the biological sample; and inputting into a programmedcomputer, through an input device, data including the results of thediagnostic analysis.

In another general aspect, the invention contemplates methods ofselecting a therapy for the patient based upon: obtaining a patientsample from a caregiver; identifying a diagnostic profile to beperformed on the sample; providing a caregiver with a mechanism forelectronically communicating the identity of the biological samplecollected from the patient and the identity of the diagnostic profile tobe performed on the biological sample to a server, wherein the patientand profile are given a unique identifier; and allowing a second user toobtain the information from the server. A. diagnostic profile mayinclude a series of tests to be run on a particular sample.

In another general aspect, equipment useful for the system can include agrossing station that can read the barcode, or otherwise input theidentifier into the system. For example, a scanner reads the barcode ona sample bag and a list of tests to be done on the sample, to provideguidance to the pathologist doing the grossing, is displayed on ascreen. It may also be able to print out the barcodes for theappropriate number of cassettes, sample tubes, or other sample holders.If the cassettes and tubes are prelabled with a barcode, the pathologistcan scan the labels to associate the barcodes with the cassettes ortubes of samples. This method allows for the automatic entry ofinformation to the database to maintain the linkage between the patientand sample and the intermediate sample carriers (cassettes and tubes).

Other equipment includes a microtome with a scanner that can read abarcode or other identifying mark. The scanner can read the barcode onthe cassette or tube (i.e., the block of sample) and allow the databaseto transmit to the pathologist or technician information about whattests are to be performed on this block of sample and/or how many slidesare to be prepared from the block of sample. It can then print out therequired number of barcodes for each of the slides to be prepared. Anauto stainer and an automated microscope that can read the identifierand extract information from the database as well as transmitinformation to the database are contemplated as well.

The scanner, or similar device to input the identifier, such as abarcode reader, can be a component separate from the laboratoryequipment or it can be integrated into the laboratory equipment. Even ifthe scanner is a component separate from the equipment, it may still bein communication with the equipment.

In still another aspect, a sample is assigned a unique identifier. Inone embodiment, the unique identifier is in the form of a barcode.Information related to the sample is received by the central databaseand associated with the unique identifier. The sample is sent to thelaboratory for processing. The laboratory is equipped with scanners forinputting the unique identifier, in this case barcode readers. At thelaboratory, the user may scan the barcode of the sample to log in whenthe sample arrived in the laboratory. This information is received andstored by the central database. The user may take the sample to thegrossing station. At the grossing station, the user may scan the barcodeinto a barcode reader. The unique identifier is received by the centraldatabase and it is noted that the sample is at the grossing station at aparticular time. The database may also transmit to the user, for exampleon a display panel at the grossing station, information about how thesample is to be prepared.

The sample may then arrive at the microtome. The identifier of thesample is scanned, and the time and location is received by the centraldatabase. The central database can then transmit more information aboutprocessing the sample. For example, an order in the central database maystate that five different slides of the sample are to be prepared fromthe original sample. There is, of course, no limitation on the number ofslides that can be prepared. The central database may transmit thisinformation to the user at the grossing station and may evenautomatically print out labels with unique identifiers to affix to eachof the five slides with the biological sample, or the system may utilizeanother means of affixing the unique identifier to the slide, such as byencoding it by laser, stamping it, or encoded magnetic strip.Alternatively, the user may place the samples on slides already assigneda unique identifier. The central database stores information about thenew samples (e.g., that the samples associated with the new fiveidentifiers are derived from the original sample, when they wereprepared, and other useful information). This recordkeeping can be donewith very little input from the user.

The slides can now be prepared for their specific test. The centraldatabase stores the information about how the sample is to be preparedand what tests are to be run on them. At each station, e.g., samplefixer, reagent dispenser, or analyzer, the sample can be scanned. Thiswould log in the sample providing information such as location and timeto be stored in the central database. It can also ensure that the slideis being processed properly. For example, if the sample is at the wrongstation, there might be a display indicting such, the station may refuseto process the slide, and/or the information is logged so that onelooking at the history of the slide would know where the error occurred.All this can be recorded without the need for the user to take anynotes.

Once the slide is processed and the test results transmitted to thecentral database, the slides may then be put aside tor storage. At thestorage area, the user can scan the slide to log it in, providing a timeand location for the slide in the central database, and set it aside. Ifa loose slide is found, the unique identifier can be scanned into thesystem to allow the central database to transmit the identifyinginformation back to the user, as well as logging in the information ofwhen and where the slide was found by noting which scanner read thebarcode and when it happened. Use of unique identifiers as describedherein allows for real time tracking as well as a convenient way tocreate a complete history of the slide with minimal input from a user.It is further contemplated that a network of laboratories can besimilarly equipped so that samples can be shared easily and effectively.

The invention may further include one or more of the followingembodiments. The unique identifier can be assigned at the moment thesample is removed from the patient's person. The unique identifier maybe assigned when the sample reaches the laboratory. It is furthercontemplated that scanners may be found throughout the facility, inareas not associated with equipment in the laboratory, such as a user'sdesk, In addition, while slides are the subject of this example, theyare only one example of the types of devices that can be used in theexamination of biological samples. Any device used to process biologicalsamples, such as tubes, cuvettes, vials, cassettes, biochips, andmicroplates, are also contemplated in the practice of the invention.Moreover, a user can be assigned an identifier. She can scan in heridentification when the sample is scanned so that the central databasecan record not only when and where the sample was scanned, but also whoscanned it in.

In another general aspect, the invention contemplates labels designed tohold information used in a laboratory equipped with scanners or otherdevices for inputting data into the system. The information may bepatient information and/or information concerning the tests to be run.The presence of the scanners reduces the need for a user to record thedata, as well as providing an efficient way to track the slides.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription, drawings, and the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a diagram of an exemplary organization of one embodiment ofthe Invention.

FIG. 2 is a diagram of an exemplary architecture of one embodiment ofthe invention.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

In one aspect, a system for tracking the relevant samples andinformation is provided. It is designed to work for a single laboratoryor for a network of laboratories and clients. In other aspects, themethods and apparatus for tracking samples and information are alsoprovided. FIG. 1 shows one example of the flow of samples andinformation.

In this example, the identifier is a printed barcode number and thesample is a tissue to be analyzed under a microscope.

1) A sample bag is received at laboratory receiving 110. The sender mayhave already used an accession workstation 180, to enter informationinto the central database 200 about the sample, such as informationabout the source of the sample, patient information, the tests required,and the barcode number of the bag and each sample container. Theaccession workstation 180 can be local or it can be at a remotelocation, such as in the surgery room where the sample may have beencollected. Inputting information can also be done at the managementworkstation 120. The management workstation 120 can also allowconfiguration of all the instruments, as well as the laboratoryinformation system (LIS), provide additional information or updateinformation already in the system, and direct the processing of thesample.

2) A receiving clerk reads the bag barcode into the system. The clerkmay also read the barcode on the package. This information could belinked to the delivery service so that the receipt of the package isautomatically acknowledged to the delivery service. The central databasefinds the record of the shipment and displays a list of the expectedcontents for the clerk to check. If the individual samples do not havetheir own barcodes, the workstation can print them (as well as recordthe numbers).

3) At the grossing station 130, the technician shows the sample barcodesto the barcode reader and a screen displays a list of how the samplesare to be divided for the requested tests. Note that no paperdocumentation needs to follow the sample because from the sample'sunique identifier, the database can send, receive, and store the neededinformation. The sample may be subdivided into the needed number ofvials or cassettes, as the case may be. If these vials or cassettes arepre labeled with unique barcodes, the operator shows them to the readerwhen he is finished to note that they are in use, otherwise the systemassigns unique identifies to be affixed to the vial or cassettes. Theunique identifiers can be affixed in any way known in the art, such asby affixing a label to the slide or imprinting it into the slide.

4) At the microtome 140, the same process is repeated, the operatorshows the barcode of the cassette to the reader and a list appears ofhow many samples need to be cut for placement onto slides. Again, if theslides are not prelabeled, the station prints out the barcodes for theslides.

5) The labeled slides are loaded into an auto stainer 150, which readsthe barcodes and checks the central database to see what stains need tobe applied to each slide.

6) Next, the slides are loaded in the automated microscope 160, whichreads the barcode to see what magnification and other parameters to useto scan the slide. Automated microscopes include ACIS (automated cellimage system) a device that scans the slides and presents images to thepathologist along with image processing tools to help in the diagnosticprocess. Apparatus for the automated analysis of samples are known inthe art, for example, they are described in U.S. Pat Nos. 6,215,892;6,330,349; 6,418,236, the contents of which are incorporated byreference in their entirety.

7) Finally, an image is displayed to a pathologist who uses the imageprocessing features of the review workstation 170 to study the image andarrive at a diagnosis.

These diagnostic quality review workstations 170 display the imagescaptured by the image acquisition system. In order to assist thepathologist in interpreting a medical image, a view station may be ableto perform a variety of image processing operations on the medicalimage. For example, the pathologist at the view stations may invokealgorithms to perform densitometry on selected regions of the medicalimage in order to identify concentration of a particular analyte withinthe tissue sample. Other image processing operations are useful forfinding objects within the image such as the nuclei of the cells,computing an integrated optical density for the nuclei of the cells andreporting the number of molecules per cell. Most image processingoperations output a fixed number (score), often falling within apredetermined range. Demographic data about the patient, which wasirrelevant to the processing of the slide, might he fetched from thecentral database and displayed at this point.

Due to the size of some medical images for a single tissue sample,typically remote viewing is unworkable if there are bandwidthconstraints. Compression algorithms can produce an image suitable fortransmission, but the data lost during compression can lead toinaccurate results from the image analysis operations.

A system can be utilized in which a remote review workstation 170 iscommunicatively coupled to an image server and receives a compressedversion of a source medical image. The remote review workstation 170 canuncompress and display the received medical image. The compressedmedical image can be transmitted over a global packet-switched networksuch as the Internet. The remote review workstation 170 can select aregion of the displayed medical image as a function of input receivedfrom a user. Based on the input, the remote review workstation 170 cantransmit region information, such as a series of pixel coordinates, backto the image server. The image server can then apply image analysisoperations to a region of the source medical image that corresponds tothe selected region of the compressed medical image. In this manner, thedata loss that occurs during image compression does not affect the imageanalysis operations. As such, the image analysis operations can producemore accurate results than if the operations were applied by the remotereview workstation 170 on the compressed image. U.S. patent applicationSer. No. 09/542,091, filed Apr. 3, 2000, the contents of which areincorporated by reference, describes a system in which images are viewedat a site remote from the location of the ACIS microscope that collectsthe images. It further describes a method for carrying out the imageprocessing at a remote site that has uncompressed versions of the imageswhile transmitting compressed images for human viewing. Other means forviewing large images electronically are known to the skilled artisan.Therefore, in situations where the review workstation 170 is connectedto the system with a limited bandwidth, e.g., over the WAN, one methodfor transmitting data involves generating a compressed medical image,transmitting the compressed medical image to a remote view station fordisplay, selecting a region of the displayed medical image, and applyingimage analysis operations to a region of the source medical imagecorresponding to the selected region of the compressed medical imaged.The image displayed for review might be compressed, but the user'srequests for image processing or scoring algorithms might be sent backto the central database for execution on uncompressed images. However,if there is no need to review the images from a remote location, e.g.,over the LAN, then there is no reason not to send an uncompressed image.

An optional feature of the system can include users being assigned theirown identifying string, such as a barcoded badge. They can then log ontoanyone of the stations by scanning their barcoded badge. One method ofutilizing the feature is to have the user log onto the station when theylog in a slide. The system can then provide information about who hashandled the slide at any given stage of its processing. This system canalso be used to assess the quality and quantity of work being handled byan individual.

Still other features of the system can include apparatus adapted for usein the system. For example, an auto stainer may be designed to use itsbarcode reader to read IDs on the bottles of reagent to track whichslides are stained with which lot of reagent. A scanner, such as abarcode reader, on a refrigerator or other sample storage space can beused to check in or check out samples for tracking purposes. Anundedicated reader, for instance at a supervisor's station, could beused to identify a loose slide. It is contemplated that other equipmentgenerally found in laboratories, not herein described, can also beadapted to transmit information to and/or receive information from thedatabase to track and provide information about the sample or theprocess it undergoes.

The system takes advantage of being able to assign unique identifiers,and utilize scanners that read them, to faithfully transmit theinformation to a database. Each time a slide or sample passes throughsome station, the database can record this event. It is, therefore,possible to provide more detailed reports and tracking information withless effort then can be done with paper based systems. For instance, ifa slide is missing, the database can provide information about whichstation it was last logged in, when it was logged in and who logged itin, without a user having written any of this information into thesystem. If a batch of reagent becomes suspect, the database can provideinformation about all the samples that used the reagent and the testresults from that use. If a stat (rush) result is needed on a sample,the database can provide in real time information about where the sampleis in the process.

The system may utilize a centralized database. One of the benefits ofusing a centralized database is that it does not matter if some steps inthe processing of the sample occur at one facility and some at another.Since all the information is being stored in one database, someoneaccessing the database will see only the seamless processing of thesample. Furthermore, if a sample is sent from one facility to another,no paperwork need accompany it as long as the sample has its uniqueidentifier. When the sample arrives at the new facility, its uniqueidentifier can be scanned to log it in, to indicate its new location andwhen it arrived.

FIG. 2 shows a block diagram of a system in which clients (who havereview and accessioning workstations 310) are sending samples toreference laboratories 320 who are preparing slides and running them onan automated cell image system (ACIS). All of them are connected via theglobal Internet 330 to a data center 340, which is storing all theinformation. Table 1 shows an exemplary division of work in theapplication of an exemplary system.

TABLE 1 Manual Event Automatic Event Sequence of Operation: For eachSlide: Client enters accessioning info DC captures accessioninginformation DC sends accessioning info to RL Client sends samples DCcenter captures shipping DC notifies RL to expect shipment RL receivesshipment DC captures receiving information RL prepares slides RL scansslides on ACIS RL ACIS sends lossless compressed images to DC RL ACISdeletes images DC sends lossy compressed images to client DC notifiesClient slides are ready for review Client uses review analysis programto view CW sends region coordinates to DC slides and select regions DCscores regions and sends scores back to CW Client releases cases CWprints report DC enters billing data in database DC archives images ifarchive fee paid then deletes from hard disk At any time: Clientrequests case status on status display CW queries DC and displaysresults [if on Client workstation the RL had barcode readers at grossingand sectioning, the display could indicate the exact stage of eachslide] Client requests re-review of archived case CW queries DC onavailability of (if they have this service) CW informs client how longtape mount will take DC operator mounts tape DC sends notification toClient Client reviews case RL = CCIC reference lab 320 Client = CCICclient CW = Client's workstation 310 DC = CCIC data center 340

Although barcodes are referred to here, any globally unique system ofidentifiers could be used, for instance letters and numbers if OpticalCharacter Recognition (OCR) readers were used. An OCR system that candistinguish 80 symbols can detect 10 quintillion (a billion billion)different 10-character labels.

In the system, each label is unique and is used to identify theinformation sent to the database and/or retrieved from the database.This allows any part of the system (within one laboratory or in otherfacilities) to work on the samples or slides without having to re-labelfor use with different equipment or for different processing steps.

Other components of the system may include an auto stainer and anautomated microscope that reads the same barcode and each extracts theinformation it needs from the database; a microtome with a barcodereader and printer, which can read the barcode on a cassette (block),look up in the database what tests are to be performed on slides cutfrom this block, and then print the required number of slide barcodes;and/or a grossing station that can read the barcode on a sample bag anddisplay a list of tests to be done on this sample for the guidance ofthe pathologist doing the grossing. It would then either print theneeded barcodes for the appropriate number of cassettes or sample tubesor otherwise encode the cassettes or samples. If they were prelabled itwould read the labels. In either case, it would automatically make therequired entries in the database to maintain the link between thepatient, sample, and the intermediate sample carriers.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. A computer program product for communicating data in a laboratory information management and control network comprising code that: receives data at a server from a single input point, said data including a first portion comprising at least one of case information, patient information and test order information, said data being entered at said single input point; stores said data in a first database managed by said server; automatically replicates said data from said first database to one or more hosts in communication with said server, a first host of said hosts controlling at least one laboratory instrument, said data being replicated without further data entry and using messages exchanged between said server and said first host; and stores said data in a second database which is local to said first host.
 2. The computer program product of claim 1, wherein said single input point is a laboratory information management system managing patient and laboratory information.
 3. The computer program product of claim 1, wherein said at least one laboratory instrument includes at least one of: an imager, a stainer, a bar code reader, a label printer, an optical scanner, an instrument that writes information to a label, and an instrument that reads information from a label.
 4. The computer program product of claim 1, further comprising code that: receives diagnostic information from a pathologist, wherein at least a portion of said information is received using at least one of: a computer entry station, a touch pad data entry device, a voice data entry device, and an interactive video with voice data entry device.
 5. The computer program product of claim 1, further comprising code that: records pathologist diagnostic information on a label associated with a sample using a data recording device in communication with one of said hosts.
 6. The computer program product of claim 1, further comprising code that: exchanges communications between said server and said host to automatically maintain a synchronized copy of said data in said first database and said second database in accordance with any updates made to said data by said server, said host, or another component in communication therewith.
 7. The computer program product of claim 3, wherein one of said instruments is an imager, said imager including a local memory or a data storage device upon which some of said data is stored.
 8. The computer program product of claim 7, further comprising code that: produces image information using said imager; stores said image information in said one of said local memory or said data storage device; uploads said image information to said second database of said host; and automatically replicates said image information to said first database and another host by exchanging messages therebetween to maintain data synchronization of shared data elements, said image information being a shared data element.
 9. The computer program product of claim 7, further comprising code that: reports, by said imager, identifying information about a sample being processed at a point in time; communicates said identifying information to said first host; and automatically replicates said identifying information to said first data and another host by exchanging messages therebetween.
 10. The computer program product of claim 1, wherein said first host controls a first set of one or more laboratory instruments operating in accordance with a first set of operations, and a second host is in communication with said first host and said server and controls a second set of one or more laboratory instruments operating in accordance with a second set of operations different than the first set of laboratory instruments.
 11. The computer program product of claim 8, further comprising code that stores a portion of said image information on a label associated with a sample.
 12. A method for communicating data in a laboratory information management and control network comprising: receiving data at a server from a single input point, said data including a first portion comprising at least one of case information, patient information and test order information, said data being entered at said single input point; storing said data in a first database managed by said server; automatically replicating said data from said first database to one or more hosts in communication with said server, a first host of said hosts controlling at least one laboratory instrument, said data being replicated without further data entry and using messages exchanged between said server and said first host; and storing said data in a second database which is local to said first host.
 13. The method of claim 12, wherein said single input point is a laboratory information management system managing patient and laboratory information.
 14. The method of claim 12, wherein said at least one laboratory instrument includes at least one of: an imager, a stainer, a bar code reader, a label printer, an optical scanner, an instrument that writes information to a label, and an instrument that reads information from a label.
 15. The method of claim 12, further comprising: receiving diagnostic information from a pathologist, wherein at least a portion of said information is received using at least one of: a computer entry station, a touch pad data entry device, a voice data entry device, and an interactive video with voice data entry device.
 16. The method of claim 12, further comprising: recording pathologist diagnostic information on a label associated with a sample using a data recording device in communication with one of said hosts.
 17. The method of claim 12, further comprising: exchanging communications between said server and said host to automatically maintain a synchronized copy of said data in said first database and said second database in accordance with any updates made to said data by said server, said host, or another component in communication therewith.
 18. The method of claim 14, wherein one of said instruments is an imager, said imager including a local memory or a data storage device upon which some of said data is stored.
 19. The method of claim 18, further comprising: producing image information using said imager; storing said image information in said one of said local memory or said data storage device; uploading said image information to said second database of said host; and automatically replicating said image information to said first database and another host by exchanging messages therebetween to maintain data synchronization of shared data elements, said image information being a shared data element.
 20. The method of claim 12, wherein said first host controls a first set of one or more laboratory instruments operating in accordance with a first set of operations, and a second host is in communication with said first host and said server and controls a second set of one or more laboratory instruments operating in accordance with a second set of operations different than the first set of laboratory instruments. 